An interventional study of RELiZORB™ and Placebo in Multi Organ Failure and Exocrine Pancreatic Insufficiency, sponsored by Inova Health Care Services. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Diagnostic
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion.
RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
This is a double-blind, placebo-controlled, parallel design study. A total of 32 adult patients who have been admitted to the Surgical or Medical Intensive Care Unit with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior.
After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 32 is below the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →Inova Health Care Services is the lead sponsor of 86 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.
Device: RELiZORB™
Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes
Other: Placebo
RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period
Time frame: Duration of intervention (5 days)
Number of intolerance-related enteral nutrition pauses
The number of unplanned enteral nutrition pauses due to enteral nutrition intolerance
Time frame: Duration of intervention (5 days)
Insulin units used
Insulin units used
Time frame: Duration of intervention (5 days)
Change in fecal elastase
Change in fecal elastase as a measure of clinical exocrine pancreatic insufficiency
Time frame: From Baseline to end of intervention at 5 days
Plan to share: No
Ran from May 2025 to primary completion in May 2026, 11 months.
Of 28 interventional studies with no phase under Multiple Organ Failure, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 11 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Aug 2026 → May 2026 and completion Aug 2026 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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